Cellex recalls Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"

Recall date

March 1, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2452-2021

FDA classification

Class II

Brand / firm

Cellex

Sold / distributed

US Nationwide distribution in the states of CA, FL, TX, and WI.

Why it was recalled

The kit does not have an emergency use authorization (EUA).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"